As the nation battles shortages of novel coronavirus (COVID-19) testing
kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency
use authorizations (EUA) process for unapproved products and uses to
accelerate the availability of diagnostic tests developed by laboratories
and commercial manufacturers during the public health emergency. The first
such EUA was
for an unapproved point-of-care test for COVID-19, which promises results
within hours, rather than days.
In conjunction with revised,
immediately in effect guidance, here are several key points laboratories and manufacturers should
consider when developing tests and obtaining approvals for their production
and use under an EUA.
- The EUA Process Requires Express FDA Review and Approval.
The Federal Food, Drug, and Cosmetic Act provides FDA with narrow EUA
authority to allow unapproved medical products or unapproved uses of
approved medical products in emergency situations. Included in the scope of
EUA issuances are products used to diagnose, treat or prevent serious or
life-threatening diseases or conditions when there are no adequate,
approved or available alternatives. To obtain an EUA from FDA for an
unapproved product or use, such as the point-of-care test for COVID-19, the
lab or manufacturer generally must submit an EUA request. FDA has provided
on its website for EUA requests for both laboratories and manufacturers.
Additionally, FDA provided a
addressing questions about the EUA process and spot shortages of testing
supplies, as well as a 24-hour hotline to answer questions (1-888-INFO-FDA,
- FDA Guidance Limits Participants. FDA provided further
clarification related to COVID-19 EUA submissions in guidance, but limited
participants to certain laboratories and manufacturers. FDA also stated
that it does not intend to object to states’ requests to authorize
laboratories or manufacturers within their borders or territories to
develop their own COVID-19 tests and perform specimen testing.
- The guidance applies to laboratories certified under Clinical Laboratory
Improvement Amendments (CLIA) that meet the CLIA regulatory requirements to
perform high-complexity testing. Such laboratories may seek to develop
diagnostic tests for COVID-19 and pursue authorization to perform the tests
through the EUA process.
- The guidance also applies to commercial manufacturers that seek to
develop diagnostic test kits and distribute them to laboratories and
healthcare professionals. FDA indicated that it does not intend to object
to a commercial manufacturer’s distribution of COVID-19 test kits for
specimen testing for a reasonable period of time (about 15 days) after the
manufacturer’s validation of the test and while the manufacturer is
preparing its EUA request. During this time, manufacturers must provide
instructions for use of the test and post data about the test’s performance
characteristics on the manufacturer’s website.
- FDA Guidance Requires Specific Standards for Efficacy Validations.
All tests must be validated as effective prior to use. FDA has provided
recommendations within the guidance that manufacturers and laboratories
should follow to ensure their products accurately detect COVID-19. Section
V of the guidance document provides the specific diagnostic tests and
standards to appropriately validate (for purposes of EUA request
submission) molecular diagnostics, antigen detection diagnostics and
serological diagnostics testing.
- FDA Will Continue to Enforce Against Fraudulent Tests. It should be noted that FDA’s guidance does not apply to at-home testing
and FDA has not approved any at-home COVID-19 tests. FDA has
consumers against these products and continues to “aggressively” monitor
the market for fraudulent marketing of such at-home kits. As of March 9,
2020, FDA and the Federal Trade Commission have issued at least
seven warning letters
to companies selling these unapproved COVID-19 treatment products, which
may subject the companies to additional legal action, including seizure of
goods or injunctions. In addition to addressing fraudulent testing, FDA has
warned consumers against the use of fraudulent vaccines or drugs to treat
or prevent COVID-19 and will continue to monitor the market and enforce
against fraudulent devices and drugs.
Laboratories and manufacturers wishing to provide COVID-19 tests should
review FDA’s guidance related to its EUA for such products. Please contact
the authors if you have questions regarding this process or FDA’s guidance
related to the COVID-19 response.
McGuireWoods has published additional thought leadership related to how companies across various
industries can navigate crucial coronavirus-related business and legal
issues, and the firm’s
COVID-19 Response Team stands ready to help clients navigate urgent and evolving legal and
business issues arising from the novel coronavirus pandemic.